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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 03/05/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfn helical blades/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: van leur, j. P. H. , jakma, t. S. C. , willemsen, s. P. , and punt, b. J. (2019), trochanteric fixation nail with helical blade compared with femoral neck screw for operative treatment of intertrochanteric femoral fractures, hip pelvis, vol. 31 (1), pages 48-56, https://doi. Org/10. 5371/hp. 2019. 31. 1. 48 (netherlands). The aim of this retrospective cohort study is to assess if there were any differences in outcomes (i. E. , cut-out and/or interventional variables) between a trochanteric fixation nail (tfn; synthes, raynham, ma, usa) with helical blade and a tfn with femoral neck screw when applied to surgical treatment of intertrochanteric femoral fractures. Between january 1, 2012 and december 31, 2016, a total of 631 patients (151 male and 480 female) with a mean age of 81. 83±11. 47 were included in the study. Of these, 239 patients (59 male and 180 female) with a mean age of 82. 53±10. 29 years were treated with a tfn with helical blade and 392 patients (92 male and 300 female) with a mean age of 81. 40±12. 13 years were treated with a tfn with femoral neck screw. Patients had a mean follow-up of one year. The following complications were reported as follows: helical blade group: 78 patients had axial migration. 5 patients had axial cut-out. 4 patients had lateral cut-out. 5 patients had non-union. 1 patient had periprosthetic fracture. 1 patient had avascular head necrosis. 1 patient had unacceptable position of the fracture/osteosyntheses. 2 patients had other complication. 1 patient had tad < 15 mm with mechanical complications. 7 patients had tad > 25 mm with mechanical complications. 53 patients had delirium. 31 patients had urinary tract infection. 1 patient had postoperative fall. 1 patient had transient ischemic attack. 1 patient had cerebral vascular accident. 3 patients had myocardial infarction. 7 patients had atrial fibrillation. 5 patients had postoperative bleeding. 14 patients had pneumonia. 1 patient had ileus. 63 patients had low hemoglobin and require transfusion. 8 patients died. Screw group: 143 patients had axial migration. 3 patients had axial cut-out. 5 patients had lateral cut-out. 5 patients had non-union. 6 patients had periprosthetic fracture. 1 patient had avascular head necrosis. 3 patients had other complication. 3 patients had tad < 15 mm with mechanical complications. 5 patients had tad > 25 mm with mechanical complications. 76 patients had delirium. 41 patients had urinary tract infection. 1 patient had thrombosis leg. 2 patients had postoperative fall. 4 patients had transient ischemic attack. 3 patients had cerebral vascular accident. 4 patients had myocardial infarction. 13 patients had atrial fibrillation. 3 patients had wound infection. 3 patients had postoperative bleeding. 20 patients had pneumonia. 1 patient had ileus. 106 patients had low hemoglobin and require transfusion. 16 patients died. This report is for an unknown synthes tfn helical blades. It captures the reported events of axial migration, axial cut-out and lateral cut-out. This is report 1 of 3 for complaint (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9536339
MDR Text Key189163981
Report Number8030965-2019-71579
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/31/2019 Patient Sequence Number: 1
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